Does Coffee Intake Reduce Postoperative Ileus After Elective Colorectal Surgery

NCT ID: NCT02469441

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2016-12-31

Brief Summary

The aim of the study is to investigate if postoperative coffee intake decreases the time until first bowel movement in elective colorectal surgery with primary anastomosis.

Detailed Description

Postoperative ileus after colorectal surgery is a frequent problem which significantly prolongs hospital stay and increases perioperative costs. Postoperative therapeutic interventions vary significantly between different hospitals due to missing evidence-based guidelines. Coffee is a safe, cheap and simple agent without significant side effects which can positively influence the bowel function.

The aim of the investigators is to evaluate in an own study if coffee consumption has an influence on the duration of postoperative ileus.

The present trial is designed to evaluate if postoperative coffee intake decreases the time until first bowel movement in colorectal surgery with primary anastomosis. This study would be the second study which evaluates the described questions under randomized conditions.

Conditions

Postoperative Ileus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm A

Arm A (treatment arm: coffee): patients after colorectal surgery receive coffee in addition to the regular infusion therapy and/or alimentation

No interventions assigned to this group

Arm B

Arm B (control arm: water / tea): patients after colorectal surgery receive water or tea (excluding black tea) and no coffee until the first bowel movement in addition to the regular infusion therapy and/or alimentation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Patients scheduled for elective laparoscopic or open colorectal surgery due to benign or malignant colorectal disease, which need a large bowel resection with primary anastomosis

• Age equal or greater than 18 years
• Patients that are able to give informed consent
• Elective Surgery
• Anastomosis above 6 cm from anal verge

Exclusion Criteria

• Participation in other studies
• Additional small bowel anastomosis
• Need for extended adhesiolysis
• Need for a stoma (e.g. protective ileostomy)
• Emergency operation with diffuse peritonitis or preexisting ileus
• Preoperative radiation
• Known hypersensitivity or allergy to coffee
• Expected lack of compliance
• Impaired mental state or language problems

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Baden

OTHER

Sponsor Role: lead

Responsible Party

Gehrer Simone

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Hasler-Gehrer, MD

Role: PRINCIPAL_INVESTIGATOR

Oberärztin

Locations

Kantonsspital Baden

Baden, , Switzerland

Countries

Switzerland

References

Hasler-Gehrer S, Linecker M, Keerl A, Slieker J, Descloux A, Rosenberg R, Seifert B, Nocito A. Does Coffee Intake Reduce Postoperative Ileus After Laparoscopic Elective Colorectal Surgery? A Prospective, Randomized Controlled Study: The Coffee Study. Dis Colon Rectum. 2019 Aug;62(8):997-1004. doi: 10.1097/DCR.0000000000001405.

Reference Type: DERIVED

PMID: 30998528 (View on PubMed)

Other Identifiers

2014-062

Identifier Type: -

Identifier Source: org_study_id